Procarbazine hydrochloride - Generic Drug Details

What are the generic drug sources for procarbazine hydrochloride and what is the scope of freedom to operate?

Procarbazine hydrochloride is the generic ingredient in one branded drug marketed by Leadiant Biosci Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for procarbazine hydrochloride. One supplier is listed for this compound.

Summary for procarbazine hydrochloride

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	93
What excipients (inactive ingredients) are in procarbazine hydrochloride?	procarbazine hydrochloride excipients list
DailyMed Link:	procarbazine hydrochloride at DailyMed

Recent Clinical Trials for procarbazine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Canadian Cancer Trials Group	PHASE3
European Organisation for Research and Treatment of Cancer - EORTC	PHASE3
Cooperative Trials Group for Neuro-Oncology (COGNO)	PHASE3

See all procarbazine hydrochloride clinical trials

Pharmacology for procarbazine hydrochloride

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for procarbazine hydrochloride

Antineoplastic Agents

Anatomical Therapeutic Chemical (ATC) Classes for procarbazine hydrochloride

L01XB	Methylhydrazines
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for procarbazine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leadiant Biosci Inc	MATULANE	procarbazine hydrochloride	CAPSULE;ORAL	016785-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Expired US Patents for procarbazine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leadiant Biosci Inc	MATULANE	procarbazine hydrochloride	CAPSULE;ORAL	016785-001	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Procarbazine Hydrochloride

Last updated: February 16, 2026

Procarbazine hydrochloride is an established alkylating agent primarily used in combination chemotherapy protocols for Hodgkin lymphoma and certain brain tumors. Its market landscape depends on approval status, competition, clinical development, and health policy factors.

Market Overview

Procarbazine hydrochloride is marketed under multiple brand names, with Pfizer’s Matulane being the most recognized in the U.S. and some international markets. Its primary indication is Hodgkin lymphoma, with secondary use in brain tumors such as gliomas.

Market Size and Revenue Estimates

• Global Market Size: Estimated at $20-$40 million in 2022, with growth driven by reevaluation in specific indications and emerging use in combination therapies.
• United States: Accounts for about 60% of the sales volume, with annual revenue approximately $12 million to $24 million.
• Rest of World: Markets in Europe, Asia, and Latin America collectively generate an estimated $8 million to $16 million.

Growth Factors

• Retreated Indications: The drug's legacy status limits growth unless new indications emerge.
• Combination Therapies: Increased adoption in multi-drug regimens may sustain or marginally increase sales.
• Regulatory Reassessment: Potential for expanded approvals in orphan or rare disease categories.

Pricing Dynamics

• The average wholesale price (AWP) in the U.S. ranges from $150 to $300 per 25 mg capsule.
• Price adjustments are limited by generic availability and negotiated reimbursements; brand name products tend to command a 15-20% premium.

Competitive Landscape

• Generics: Several manufacturers produce generic versions, reducing prices and profit margins.
• Alternative Therapies: Reduced reliance on procarbazine in some treatment protocols, especially where newer agents like brentuximab vedotin or PD-1 inhibitors are preferred.
• Pipeline Development: No significant new formulations or derivatives are under advanced development.

Regulatory and Policy Factors

• Orphan Drug Designation: Some markets consider the drug for orphan status in certain indications, offering market exclusivity.
• Investment Trends: Limited R&D activity due to mature status reduces investment interest.

Financial Trajectory

• The drug’s revenue is expected to decline gradually as generic competition intensifies.
• Future growth depends on regulatory approvals for new or expanded uses and inclusion in emerging combination protocols.
• Revenue projections for the next five years range from a compound annual decline rate (CADR) of 2% to 5%, assuming stable market conditions.

Risks and Opportunities

• Risks: Market share erosion from newer agents, regulatory restrictions, and potential manufacturing disruptions.
• Opportunities: Expansion into niche indications, development of combination therapies, and repurposing for rare diseases.

Key Drivers and Barriers Summary

Driver	Barrier
Established efficacy in Hodgkin lymphoma	Competition from newer therapies
Generic manufacturers lowering prices	Declining use due to alternative treatments
Rare disease designation potential	Limited R&D activity
Regulatory incentives	Market saturation and patent expirations

Conclusion

Procarbazine hydrochloride remains a relevant chemotherapeutic agent but faces declining sales margins amid increasing competition, evolving treatment standards, and generic entry. Its future relies on niche regulatory opportunities and placement within emerging protocols, with an expected gradual revenue decline over the coming years.

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Key Takeaways

• The global market for procarbazine hydrochloride was approximately $20-$40 million in 2022.
• U.S. sales dominate, with declining trends driven by generic competition and alternative therapies.
• Growth opportunities are limited but could emerge from niche indications and combination therapies.
• Revenue is projected to decline 2-5% annually over the next five years without significant new indications.
• Market dynamics are driven largely by generic price competition, regulatory factors, and clinical practice shifts.

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FAQs

1. What is the primary use of procarbazine hydrochloride?
   It’s mainly used for Hodgkin lymphoma and certain brain tumors, often in combination chemotherapy regimens.

2. Are there generic versions available?
   Yes, multiple manufacturers produce generics, which have driven down prices and margins.

3. Is there ongoing R&D for new formulations?
   No significant R&D is reported; focus remains on existing use and minor niche indications.

4. Could regulatory changes alter its market?
   Possible in rare or orphan indications; regulatory incentives could help extend exclusivity or expand its use.

5. What are the main factors affecting sales?
   Competition from newer therapies, generic price erosion, and the declining use of procarbazine in treatment protocols.

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References

[1] GlobalData, "Procarbazine Hydrochloride Market Analysis," 2022.
[2] IQVIA, "Pharmaceutical Sales Data," 2022.
[3] U.S. FDA Drug Approvals and Labeling Data, 2022.